Clinical Trials Regulatory Specialist 1

Responsibilities

Independently develop, draft and compile research protocol documents and all materials required for regulatory submissions in compliance with University and external policies

Manage and oversee new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support

Facilitate and participate in committee meetings, ensure procedures are followed. Responsible for compiling, organizing, and storing all session documentation and communicating results as appropriate

Revise submissions for identified problems and issues and resolve any procedural issues that might arise in order to ensure timely response; advise investigator on remedies and revisions

Maintain regulatory documents, monitor and recommend improvements for tracking regulatory documents. May assist with registering and reporting of clinical trials, i.e. ClinicalTrials.gov

Collaborate on development of standard operating procedures, trainings, and documentation. May participate in delivering trainings

Stay current on federal, state, and local regulations regarding clinical research and communicate changes to study staff and recommend related changes to leadership

May serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees

May co-author committee responses to investigators, assure these are reviewed, signed by the Chairperson, and communicated promptly to the necessary parties

Benefits

Career development programs tailored to professional growth

Comprehensive benefits supporting financial stability and work-life balance

A culture rooted in excellence, innovation, collaboration, and lifelong learning

Glassdoor

4.0

Stanford Medicine improves health through leadership, diversity and collaborative discoveries and innovation in health care, education and research.

Stanford, California, USA

https://med.stanford.edu/scgpm.html

Late Stage

Leadership Team

Laila Soudi

Co-Founder, Co-Director MENA Health Program

Monica Hanson

Co-Founder and Director, (ACT), CCARE, Research Center at Stanford School of Medicine

Recent News

Business Wire

The Foundation for the National Institutes of Health Announces Recipients of the Deeda Blair Research Initiative for Disorders of the Brain

2026-05-20

BioSpace

NeuroDex and Stanford Researchers Publish First Evidence of CNS Target Engagement for GLP-1 and PPARγ Agonists Using Blood-Based Neuron-Derived Extracellular Vesicles

2026-04-23

News-Medical.Net

AI predicts retinal age to identify early signs of biological aging

2026-04-22

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Qualifications

Bachelor's degree and three years of related experience or a combination of education and relevant experience

Excellent communication skills and superb attention to detail

Experience with MS Office products and database applications required

Excellent inter-personal skills and customer service focus is required

Experience in clinical trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB

Knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice

Strong writing skills

Bachelor’s degree and three years of related experience or a combination of education and relevant experience.

Required skills

Clinical Trials Operations, FDA Regulations, IRB Review and Approval, Clinical Practice, Microsoft Office

Experience

3+ years